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Last Updated: February 18, 2020

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CLINICAL TRIALS PROFILE FOR AMILORIDE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Amiloride Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00590538 Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Cystic Fibrosis Foundation Therapeutics Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
New Combination NCT00590538 Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Children's Hospital of Philadelphia Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Amiloride Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004705 Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis Completed University of North Carolina N/A 1996-09-01 OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.
NCT00004705 Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis Completed FDA Office of Orphan Products Development N/A 1996-09-01 OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.
NCT00007592 Hypertension Screening and Treatment Program Completed VA Office of Research and Development N/A 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00141596 Extracellular Fluid in Resistant Hypertension Terminated St George's, University of London N/A 2003-07-01 The optimal treatment of drug resistant (defined as BP> 140/85 despite three anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test the hypothesis that resistant hypertension is caused by excessive expansion of extracellular fluid volume. A secondary objective is to study which of three different antihypertensive drugs would be most useful in drug resistant hypertension.
NCT00224549 PHARES Study: Management of Resistant Hypertension Completed Assistance Publique - Hôpitaux de Paris Phase 4 2005-04-01 The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.
NCT00274391 Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis Completed Cystic Fibrosis Foundation Therapeutics Phase 2 2001-07-01 The purpose of this research study is to determine whether the combination of inhaled amiloride and a concentrated salt solution is better than the salt solution itself for cystic fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. Many patients use inhaled salt solutions to help draw water into their secretions so that they are easier to get rid of with chest physiotherapy (“chest PT”) and cough. Unfortunately, these salt solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last very long. In the hopes of prolonging their effects, the drug amiloride could be used in combination to slow salt and water reabsorption from airways. Amiloride is a medication that has been given by mouth for high blood pressure for many years. It is possible that the combination of salt solutions and inhaled amiloride may significantly improve the clearance of secretions in CF, which would be expected to improve lung function in CF.
NCT00274391 Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis Completed University of North Carolina Phase 2 2001-07-01 The purpose of this research study is to determine whether the combination of inhaled amiloride and a concentrated salt solution is better than the salt solution itself for cystic fibrosis (CF) patients. In CF, airway secretions are thick and dehydrated. Many patients use inhaled salt solutions to help draw water into their secretions so that they are easier to get rid of with chest physiotherapy (“chest PT”) and cough. Unfortunately, these salt solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last very long. In the hopes of prolonging their effects, the drug amiloride could be used in combination to slow salt and water reabsorption from airways. Amiloride is a medication that has been given by mouth for high blood pressure for many years. It is possible that the combination of salt solutions and inhaled amiloride may significantly improve the clearance of secretions in CF, which would be expected to improve lung function in CF.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amiloride Hydrochloride

Condition Name

Condition Name for Amiloride Hydrochloride
Intervention Trials
Hypertension 18
Cystic Fibrosis 7
Chronic Kidney Disease 2
Insulin Resistance 2
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Condition MeSH

Condition MeSH for Amiloride Hydrochloride
Intervention Trials
Hypertension 20
Fibrosis 7
Cystic Fibrosis 7
Kidney Diseases 4
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Clinical Trial Locations for Amiloride Hydrochloride

Trials by Country

Trials by Country for Amiloride Hydrochloride
Location Trials
United States 28
Brazil 14
France 8
United Kingdom 7
Denmark 6
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Trials by US State

Trials by US State for Amiloride Hydrochloride
Location Trials
Pennsylvania 3
North Carolina 3
Indiana 2
District of Columbia 2
Alabama 2
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Clinical Trial Progress for Amiloride Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Amiloride Hydrochloride
Clinical Trial Phase Trials
Phase 4 14
Phase 3 8
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Amiloride Hydrochloride
Clinical Trial Phase Trials
Completed 23
Recruiting 13
Not yet recruiting 9
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Clinical Trial Sponsors for Amiloride Hydrochloride

Sponsor Name

Sponsor Name for Amiloride Hydrochloride
Sponsor Trials
Hospital de Clinicas de Porto Alegre 6
Assistance Publique - Hôpitaux de Paris 5
Cystic Fibrosis Foundation Therapeutics 3
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Sponsor Type

Sponsor Type for Amiloride Hydrochloride
Sponsor Trials
Other 102
Industry 6
U.S. Fed 3
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